Certification service is available to overseas customers who seek independent third party services to verify their facility and biosafety and biosecurity programs meets nationally (Singapore, MOH), or internationally required standards (US CDC standards to be eligible to receive funds from NIH grants). It is important to understand why certification is available overseas but is not…
Author: jstalzer
Consultation Services
Biosafety and Biosecurity Consultation Many of our customers seek biosafety reachback capability for technical guidance on interpretation of regulatory requirements, development or third party review of operating procedures and guidance documents, review of design specifications and architectural drawings and other areas regarding biosecurity and biocontainment. Most often we are called upon to provide day-to-day support…
Onsite Staffing and Mentoring
When research involves work with pathogens, toxins or Select Agents it is vital, and in the case of the select agent program it is legally required that there be a biosafety officer (responsible official) on-site. The US faces a shortage of biosafety professionals, and biosafety officers with actual experience working inside containment labs. The reason…
Training and Education
Understanding the importance of training and the need to achieve the desired outcome, a working group convened by the CDC recently published recommendations for biosafety competencies for individuals working in the lab. Providing effective safety training and mentoring is a cornerstone of biosafety and is universally instituted in academia, government and industry. Training is also…
Select Agent Registration
Registration is one of the most rigorous and complex processes your organization and people will undertake. We have assisted organizations in preparing for the Registration process, and because we understand the documentation, personnel and facility requirements we can help streamline the workload and the time it takes to prepare for SAP submissions and inspection. We…
Program Development
Program Development and Baseline Review Whether your institute is in the design/construction phase, or planning on conducting work with infectious material or biological toxins, a biosafety and biosecurity program must be developed and implemented before work begins. Under the best conditions, these programs inform design and are developed from the start of the design process….
Design/Build
Getting the Laboratory You Need and Expect When your plans involve new construction or renovation of existing spaces we provide an integrated approach to design planning, review and construction inspection to ensure the laboratory/facility meets the intent of the BMBL and other documents as relevant to the project (i.e. NIH DRM, ARS design standards, animal…